Mobile App for Multiple Myeloma

(THRIVE-M Trial)

Overseen By Hermioni Amonoo, MD, MPP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Acute psychiatric, Unstable cognitive, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app called THRIVE-M to determine if it can help people with multiple myeloma feel better by reducing stress and fatigue and improving overall quality of life. Participants will either use the app or continue their usual care. The app assists users in managing symptoms, communicating needs, and focusing on self-care. Individuals diagnosed with multiple myeloma and currently receiving treatment might be suitable for this study. As an unphased trial, this study provides a unique opportunity to explore innovative methods to enhance well-being and self-care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on evaluating a mobile app for improving quality of life, so it's likely you can continue your usual treatment.

What prior data suggests that the THRIVE-M mobile app is safe for patients with multiple myeloma?

Research has shown that THRIVE-M, a mobile app for mental and physical support, is being tested to determine its effectiveness in improving the well-being of people with multiple myeloma, a type of cancer. Early results suggest that THRIVE-M is generally safe, with no major side effects reported. The app assists patients in managing symptoms, expressing their needs, and practicing self-care. Since this trial involves an app rather than a drug, the risks are lower compared to traditional medical treatments. So far, participants appear to handle the app well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

THRIVE-M is unique because it leverages a mobile app to empower patients with multiple myeloma to manage their condition more effectively. Unlike traditional treatments that focus primarily on medication, THRIVE-M emphasizes coping with physical symptoms, improving communication, and enhancing self-care through digital tools. Researchers are excited about this approach because it provides personalized support and education, potentially improving quality of life and patient outcomes while complementing existing care methods.

What evidence suggests that the THRIVE-M app is effective for improving quality of life in multiple myeloma patients?

Research has shown that the THRIVE-M mobile app, available to participants in this trial, can help people with multiple myeloma manage their condition more effectively. In earlier studies, 87% of participants found the app at least somewhat helpful in managing symptoms and feeling more at ease when seeking help. The app assists users in coping with physical symptoms, understanding their needs, improving relationships, and focusing on self-care. By employing these methods, THRIVE-M aims to enhance quality of life and reduce stress and fatigue for those living with multiple myeloma. ^{1 2 3 4 6}

Who Is on the Research Team?

Areej El-Jawahri, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adults 18+ with multiple myeloma, whether newly diagnosed on first-line therapy, on maintenance therapy, or receiving their 2nd or 3rd line of treatment. Participants must understand and respond to English. Those with acute psychiatric conditions or unstable cognitive issues that prevent informed consent are excluded.

Inclusion Criteria

I am 18 or older with multiple myeloma and currently on maintenance therapy.

I am an adult with multiple myeloma undergoing my 2nd or 3rd treatment.

Ability to comprehend, read, and respond to questions in English

Exclusion Criteria

Patients with acute or unstable psychiatric conditions that prohibit informed consent or compliance with study procedures

I am able to understand and follow the study's requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the THRIVE-M mobile application to improve quality of life, psychological distress, and fatigue

8 weeks

Questionnaires completed in person, over the computer, or by mail

Follow-up

Participants are monitored for safety and effectiveness after treatment using various scales and questionnaires

7 weeks

What Are the Treatments Tested in This Trial?

Interventions

• THRIVE-M

Trial Overview The trial tests the THRIVE-M psychosocial mobile app's effectiveness in improving life quality, reducing psychological distress, and alleviating fatigue among multiple myeloma patients compared to those who receive usual care without the app.

How Is the Trial Designed?

Group I: THRIVE-M Experimental Treatment 1 Intervention

Participants will be recruited from the Massachusetts General Hospital Cancer Center and randomized in a 1:1 fashion, stratified by diagnosis type (newly diagnosed versus maintenance versus relapsed), to THRIVE-M versus usual care. Participants will use THRIVE-M following a diagnosis of multiple myeloma to learn how to cope with physical symptoms, articulate their needs and navigate relationships, and focus on self-care while living with multiple myeloma using an iPad provided by the study team or the participant's own iPad. Questionnaires (in person, over the computer or telephone, or by mail) will be completed by participants at predetermined days per protocol days.

Group II: Usual Care Active Control 1 Intervention

Participants will be recruited from the Massachusetts General Hospital Cancer Center and randomized in a 1:1 fashion, stratified by diagnosis type (newly diagnosed versus maintenance versus relapsed), to THRIVE-M versus usual care. Questionnaires (in person, over the computer or telephone, or by mail) will be completed by participants at predetermined days per protocol days. Participants in the usual care arm will receive their usual care with the multiple myeloma team, including all routine supportive care resources (e.g., support from social work, psychology, or psychiatry) offered by the multiple myeloma team to all patients diagnosed with multiple myeloma. Patients in both the usual care and THRIVE-M group are permitted to use all supportive care services per usual care. We will track referrals to supportive care services in both groups by reviewing the Electronic Health Record (EHR).

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

In a study of 148 newly diagnosed multiple myeloma patients in Mexico, those treated in private healthcare systems had significantly better outcomes, with 65% achieving a very good partial response compared to 41% in public hospitals.

Patients in private care also had longer median progression-free survival (41 months vs. 23 months) and overall survival (79 months vs. 51 months), highlighting the impact of access to novel treatments and stem cell transplantation on survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of the affordability of novel agents in patients with multiple myeloma: Real-world data of current clinical practice in Mexico. Tarín-Arzaga, L., Arredondo-Campos, D., Martínez-Pacheco, V., et al.[2019]

The 'MM E-coach' is a newly developed e-health application designed to enhance patient-centered care for multiple myeloma patients, featuring modules for medication management, patient-reported outcomes, and communication with healthcare providers.

Initial usability testing showed a median score of 60 out of 100, indicating moderate usability, with positive feedback on its features from both patients and healthcare professionals, and a randomized clinical trial is underway to assess its clinical effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and development of an e-health application to deliver patient-centered care during treatment for recently diagnosed multiple myeloma patients: pilot study of the MM E-coach. Geerts, P., Eijsink, J., Moser, A., et al.[2023]

Multiple myeloma (MM) patients experience significant health-related quality of life (HRQoL) challenges, particularly at diagnosis and relapse, highlighting the need for effective monitoring of their condition.

Digital health technologies, such as telemedicine and mobile health, have the potential to improve health outcomes for MM patients, but face barriers like limited access for older patients and a lack of integration with existing healthcare systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Health for Patients With Multiple Myeloma: An Unmet Need. Jagannath, S., Mikhael, J., Nadeem, O., et al.[2021]

The Alexa skill Multiple Myeloma, launched in September 2019, provides patients with expert-reviewed information about multiple myeloma, including disease details, diagnostics, and therapy options, making it a valuable resource for patient education.

With 141 installations and 189 skill sessions analyzed, the skill effectively connects users to local patient support groups and offers interactive quizzes, although concerns about data protection and lack of need were barriers for some potential users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Convenient Access to Expert-Reviewed Health Information via an Alexa Voice Assistant Skill for Patients With Multiple Myeloma: Development Study. Baertsch, MA., Decker, S., Probst, L., et al.[2022]

A study involving 30 multiple myeloma patients showed that exercise therapy is safe and feasible, with no adverse events reported during the program.

Among those who adhered to the exercise regimen, significant improvements in physical functioning and a trend towards reduced fatigue were observed, suggesting that exercise may enhance quality of life for MM patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical exercise therapy program with multiple myeloma patients: Impacts on feasibility, adherence and efficacy. Wefelnberg, MM., Niels, T., Holtick, U., et al.[2023]

Approximately 40% of multiple myeloma patients do not meet the criteria for phase 3 clinical trials, highlighting the need for treatment decisions that consider real-world factors like patient adherence, treatment feasibility, and quality of life.

Individual patient perspectives on treatment efficacy vary widely, necessitating a personalized approach to therapy that incorporates each patient's unique goals and experiences throughout their treatment journey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of patients with multiple myeloma beyond the clinical-trial setting: understanding the balance between efficacy, safety and tolerability, and quality of life. Terpos, E., Mikhael, J., Hajek, R., et al.[2021]

The I-Can Manage program was developed through a user-centered co-design process involving 16 cancer patients and 19 clinicians, focusing on self-management of treatment toxicities with evidence-based content and features tailored to patient needs.

Usability testing showed high patient satisfaction with the program, indicated by a mean score of 3.75 on the Post-Study System Usability Questionnaire, suggesting it effectively supports patients in managing their cancer treatment side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Web-Based Cancer Self-Management Program (I-Can Manage) Targeting Treatment Toxicities and Health Behaviors: Human-Centered Co-design Approach and Cognitive Think-Aloud Usability Testing. Howell, D., Bryant Lukosius, D., Avery, J., et al.[2023]

A study involving haematology specialists across three cancer networks in NHS Scotland identified 21 essential patient assessment skills for pharmacist independent prescribers who prescribe immunomodulators for myeloma patients.

The research highlights the collaborative role of pharmacist independent prescribers alongside consultants, suggesting that these skills could also be applicable for prescribing treatments for other blood cancers, aiding in the development of a competency framework for training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What patient assessment skills do pharmacist independent prescribers require to prescribe immunomodulators in myeloma? Slavin, A., Kurdi, A., Wilson, M.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06073353?intr=nicotine&aggFilters=status:not%20rec%20act&page=1&rank=3

Psychosocial Mobile Application (THRIVE-M) for Patients ... This clinical trial aims to evaluate whether a psychosocial mobile application (THRIVE-M), is efficacious for improving quality of life, psychological distress, ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37410541/

A Mobile App to Support Self-Management in Patients with ... Most participants found the app at least moderately effective at helping manage symptoms (87%), feeling more comfortable seeking help (87%), ...

3. careacross.com careacross.com/clinical-trials/trial/NCT06073353

Psychosocial Mobile Application (THRIVE-M) for Patients ... THRIVE-M is a self-administered psychosocial mobile application for patients living with multiple myeloma that includes the following five modules.

4. withpower.com withpower.com/trial/phase-multiple-myeloma-9-2023-454ab

Mobile App for Multiple Myeloma (THRIVE-M Trial) Trial Overview The trial tests the THRIVE-M psychosocial mobile app's effectiveness in improving life quality, reducing psychological distress, and alleviating ...

5. trialx.com trialx.com/clinical-trials/listings/285144/psychosocial-mobile-application-thrive-m-for-patients-with-multiple-myeloma/?&geo_lat=42.4829&geo_lng=-71.1574&radius=10&place=Woburn&user_country=United%20States

Psychosocial Mobile Application (THRIVE-M) for Patients ... This clinical trial aims to evaluate whether a psychosocial mobile application (THRIVE-M), is efficacious for improving quality of life, ...

6. sparkcures.com sparkcures.com/clinical-trials/multiple-myeloma

Multiple Myeloma Clinical Trials We help myeloma patients find, understand and connect with their clinical trial options at centers around the US.